Primary Mitochondrial Myopathy Clinical Trial
Official title:
A Randomized, Double-blind, Placebo-controlled Phase 2 Study to Assess the Efficacy, Safety and Tolerability of ASP0367 in Participants With Primary Mitochondrial Myopathy
The purpose of this study is to evaluate the dose response of ASP0367 on functional improvement relative to placebo, safety, and tolerability in participants with Primary Mitochondrial Myopathy.
Efficacy (i.e., functional improvement) will be assessed by a functional motor test, 6-minute walk test (6MWT). The study consists of the following portions: screening (4 weeks); double-blind treatment period with 2 doses of ASP0367 vs matching placebo (24 weeks) and follow up (4 weeks). Participants will be randomly placed into 1 of 3 arms (low dose ASP0367, high dose ASP0367 or placebo). ;
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